Product Description - Preston Hard Bone Instrucciones De Uso

PRODUCT DESCRIPTION

The Preston™ Hard Bone Introducer is designed to traverse hard bone, allowing access for a subsequent bone
biopsy procedure (supplied separately). The product has the following contents. For specific sizes, see Table #1.
INDICATIONS FOR USE
Traversing hard bone to allow for a subsequent bone biopsy procedure. To be used with Westbrook™ Bone Biopsy
System or Kensington™ Guide Wire Bone Biopsy System in corresponding lengths (supplied separately, see Table
#2).
PRECAUTIONS
The device must only be used by a physician trained to carry out biopsies or radiology interventions, or under his/
her supervision. The device is supplied in a sterile state and should be considered as such unless the packaging has
been opened or is damaged. Do not use if the packaging is damaged. When using equipment from other suppliers,
check that their length and diameter are compatible with the components of the device. When in use, only apply
pressure with your fingers and ensure that you do not apply excessive axial pressure or bend the elements. After
use, this product may pose a potential biological risk. All products of this type must be handled and destroyed in
accordance with accepted medical practices, legislation and applicable provisions.
STORAGE
Store in a cool, dry place (below 26° C), away from humidity and direct heat. Do not use after the expiry date.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient
injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the
patient.
CONTRAINDICATIONS
Contraindicated for use on patients who are receiving heavy anticoagulant therapy or who have a severe bleeding
problem. Prior to procedure, patient's medical records should be carefully checked for any history of hemorrhagic
activity.
DIRECTIONS FOR USE
The following is a suggested method for using the device. The procedure should be accurately planned and
executed using diagnostic imaging and clinically approved techniques. If while following the instructions for use
for the Westbrook Bone Biopsy System or Kensington Guide Wire Bone Biopsy System you need to use the Preston
Hard Bone Introducer of corresponding length (supplied separately, see Table #2) to pass through hard bone to
reach the biopsy site, follow these instructions.
FIG. 1 With the Stylet removed, insert the Guide Rod (A)
through the Blunt Cannula that is already in place,
until in contact with the bone.
FIG. 2 Hold the Guide Rod (A) firmly against the bone and
withdraw the Blunt Cannula.
FIG. 3 Unlock and remove the Drill Insert (C) from the
Cutting Cannula (B). Slide the Cutting Cannula (B)
down over the Guide Rod (A) until in contact with
the skin. Introduce the Cutting Cannula (B) by
rotating counterclockwise, until in contact with the
bone.
Note: To protect soft tissue, a counterclockwise
rotation must be applied during Cutting Cannula
(B) insertion through the soft tissue.
FIG. 4 Withdraw the Guide Rod (A) while holding the
Cutting Cannula (B) firmly against the bone.
FIG. 5 Move the depth gauge on the Cutting Cannula (B)
forward until in contact with the skin, then adjust it
depending on the depth of the lesion for biopsy to
the appropriate centimeter marker and tighten to
provide a visual guide.
Introduce the Drill Insert (C) into the Cutting
Cannula (B) and lock the handles together.
Note 1: It may be necessary to withdraw the
Cutting Cannula (B) by approximately 2mm in order
to lock the handles.
With careful but firm turns, rotate the Cutting
Cannula and Drill Insert (B+C) clockwise until the
depth gauge reaches the skin and/or desired
position is obtained.
Note 2: To maintain penetration efficiency during
drilling, it is recommended to remove the Drill
Insert (C) from time to time and remove any bone
debris from the drill grooves.
Hard Bone Introducer
I N S T R U C T I O N S F O R U S E
A
A Guide Rod
B Cutting (Access) Cannula
C
Drill Insert
B
ENGLISH
C